FDA.reportPublic FDA data

PROFORMA

Primary DI
20653405051241
Brand
PROFORMA
Company
Conmed Corporation
Model
050320
Catalog number
050320
Device description
PROFORMA Cannula, Long Tapered Tip, Pre-Curved
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODDEndoscopic retrograde cholangiopancreatography (ERCP) cannula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) CannulaGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950700000BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULAC.R. Bard, Inc.1995-04-27ODD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405051244PackageGS13Not in Commercial Distribution
20653405051241PrimaryGS10
00653405051247Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340505124410653405051244
2065340505124120653405051241
00653405051247006534050512476534050512470653405051247

GMDN Terms#

Term, Definition table
TermDefinition
ERCP catheter, non-balloon, non-electrical, single-useA non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Device Size Text, specify0
Length200Centimeter
Outer Diameter0.035Inch
Outer Diameter0.89Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
Device count
3
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170466045Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466052Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466069Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466076Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466083Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466090Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466106Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466113Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
04953170466120Single Use 2-Lumen Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466042Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466059Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466066Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466073Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466080Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466097Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466103Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466110Single Use Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
14953170466127Single Use 2-Lumen Cannula VOLYMPUS MEDICAL SYSTEMS CORP.ODD2025-06-12
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